Hepatocellular carcinoma
Conditions
Interventions
Continuous TACE
Sorafenib
Sponsors
The University of Tokyo, Department of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with advanced hepatocellular carcinoma diagnosed by histology or imaging 2. Patients with hepatocellular carcinoma refractory to TACE according to the following criteria: Lipiodol deposit is less than 50% or multiple new lesions appear 3 months after TACE. 3. Patients who is indicated for sorafenib.
Exclusion criteria
Exclusion criteria: 1.Patients who received sorafenib or molecular target drug in the past 3 months. 2.Patients receiving the treatment (other than study drug or procedure) for HCC. 3.Patients who have an allergic history to the study drug. 4.Patients during pregnancy, breast-feeding, or at risk of becoming pregnant. 5.Patients without indication for TACE. 6.Patients on dialysis. 7.Patients with poorly-controlled hypertension (systolic blood pressure > 170mmHg on medication) 8.Patients with esophageal varices who have a risk for bleeding, or the patients with the history of gastrointestinal hemorrhage within a month. 9.Patients with current or past history of hepatic encephalopathy. 10.Patients with a history of liver transplantation. 11.Patients receiving drugs that affect CYP3A4 or UGT1A9 (e.g.Rifampicin). 12.Patients with other primary malignancies. 13.Patients infected with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). 14.Patients considered inappropriate by the study investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Objective Response Rate Change rate of tumor markers Safety profile | — |
Countries
Japan
Contacts
Public ContactMasaya Sato
The University of Tokyo Department of Gastroenterology
Outcome results
None listed